In research intensive regulated industries, information is the source of innovation, and many content and information sources feed the research and product development pipeline. The ability to create, share, reuse, navigate, find, and protect essential information is critical to getting products approved by regulators and launched successfully.
Much of the information created, shared, and reviewed/approved today is captured across multiple databases, repositories and mainly in information artifacts and unstructured documents developed throughout the product development life cycle. The information captured in unstructured documents or a set of unstructured documents compiled into information artifacts such as submission dossiers are published to submit to regulatory agencies for product approvals. Many of these dossiers or documents are comprised of sub-components which are themselves comprised of content generated by experts, scientists, and systems, increasing both the complexity and volume of information about a product. The information artifacts and documents created and managed within these tools have been largely used to create flat structures (i.e. documents). These formats do not lend themselves to structuring the content within the document, and have hindered enhanced uses of the information to exploit the knowledge for key needs, such as reuse across documents and systems, change impact assessments and decisions.
Structuring the information within these information artifacts into meaningful re-usable components, and being able to create intelligence (applying metadata, defining the relationships) about the components is essential to making key decisions during the information generation, authoring, review, and approval processes for quality, consistency, and improved efficiencies. Maintaining traceability of reused components will facilitate easier assessment of impacts of component changes.
Enterprise Information Management (EIM) solutions supported by Component Content Management (CCM) and/or Structured Content Management (SCM) systems will improve quality, consistency, and deliver significant value and efficiencies in creating, reviewing, and approving the thousands of related compilations of information or documents created through the product development life cycle. Structuring the content also promotes easier methods for downstream uses of the information currently embedded in documents by allowing the appropriate components of content to be published/output into required formats for downstream systems or applications.
In the current state of technology, there is a lack of user-friendly tools to facilitate easy ways to manage the foundational information models that represent the structure of a compilation of information, such as regulatory submissions dossiers or documents in the biopharmaceutical industry, or other regulated industries. Existing tools in use do not provide productivity tools that are easy to use, dynamically configurable and extensible to manage the end-to-end processes for structured component content management and authoring. Additionally, the traditional technologies that are implemented using relational databases are difficult to extend in a user-friendly manner.